Cleared Abbreviated

SNAP EEG MONITOR (K020218) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K020218 · Nicolet Biomedical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
90d
Days
Class 2
Risk

K020218 is an FDA 510(k) clearance for the SNAP EEG MONITOR. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Nicolet Biomedical, Inc. (Stoughton, US). The FDA issued a Cleared decision on April 22, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nicolet Biomedical, Inc. devices

Submission Details

510(k) Number K020218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2002
Decision Date April 22, 2002
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code OLW Index-generating Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OLW Index-generating Electroencephalograph Software

All 37
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K020218.
BIS™ Advance Monitoring System
K230693 · Covidien, LLC · Feb 2024
Brain Anesthesia Response Monitor (Bar Monitor)
K213273 · Cortical Dynamics , Ltd. · Sep 2023
Masimo SedLine Sedation Monitor and Accessories
K203113 · Masimo Corporation · Feb 2022
NeuroSENSE Monitoring System, Model NS-901
K202621 · Neurowave Systems, Inc. · Aug 2021
SedLine Sedation Monitor
K172890 · Masimo Corporation · Jan 2018